There are multiple departments, business units, vendors, and stakeholders involved in Life Sciences compliance and the Open Payments process. With the multitude of moving parts, it is common to experience challenges in reporting, timeliness, and accuracy of these data. Moreover, there are challenges with communication to healthcare professionals (HCPs) and the various players involved in this process. This blog series is intended to identify the various perspectives involved in defining challenges and issues and to provide potential discussion points and solutions for the reader.
What Are the Challenges to a Life Sciences Organization?
Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* illuminated the following:
- More than 40% of respondents said compliance was the greatest challenge at their organization; and
- 82% of respondents said increasing compliance was the most important HCP engagement initiative.
Several key challenges to more successful compliance management surfaced, including:
- 72% noted multiple, disparate systems for the capture and reporting of data was their biggest problem;
- 48% indicated multiple vendors handling their tracking and reporting of HCP data was a challenge;
- 43% of respondents reported HCP data accuracy was a challenge; and
- 42% of respondents cited lack of internal and external resources to handle data tracking and reporting as a challenge.
*The full study is available here.
Compliance Within the Life Sciences Organization
Across the Life Sciences industry, the primary purpose of any organization is to deliver quality patient care and/or healthcare solutions for patients. Clinicians, scientists, and other employees strive to bring innovative products to market that will benefit patients across the age spectrum. Compliance drives many of the decisions in developing new products. There are a host of laws, best practices, and guidelines associated with drug/device development and commercialization, such as clinical regulatory compliance, legal compliance associated with anti-bribery, anti-kickback laws, and ethical accounting practice statutes, among many others. Employees across the Life Sciences organization may find themselves saying, “I am not a compliance officer; my job is ‘X’ or my responsibility is ‘Y’ and has nothing to do with a regulations or a compliance program.”
Yet the expectation is or should be that everyone has the responsibility for doing the right thing. Organizations must create a culture whereby each employee upholds the highest ethical and professional standard as general practice. Several industry leaders’ mantra is to have a thorough and robust compliance program addressing the myriad of risks associated with bringing new products to market. Yet it must also be one that promotes ease of adherence. Processes, operational checklists, and audit practices are all necessary but there needs to be a universal definition of compliance instead of a fragmented description. Leaders driving compliance are really seeking employees to create and embrace an ethical barometer. They must ask themselves not only, “Can I do it?” but “Should I do it?” Once that is answered, the how needs to be easy, trackable, and monitored.
What Can a Life Sciences Organization Do to Improve Compliance?
Any good compliance program at a Life Science organization starts with key stakeholder identification. Different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. Some organizations handle this internally whereas others outsource this task to a third party. It doesn’t matter who handles it as long as they have a firm understanding of the organization’s needs and a process for the accurate and timely capture and reporting of the data. Based on AHM’s experience, we recommend the following:
- As your organization begins to analyze its compliance process to ensure accurate and timely reporting, it is crucial to identify all the parties involved and their level of commitment and expectations. Various departments may include: legal, compliance, medical affairs, meeting management services, accounting, the compliance officer, and administration.
- Schedule regular meetings with all parties involved to discuss the objectives, process and timeline for adhering to SOPs and reporting requirements to ensure understanding and expectations.
- Ensure that each vendor understands your internal compliance, data collection, and reporting requirements so they adhere to processes and provide the data in a format you can understand and use.
- Continually communicate the process to the HCP in a clear and concise manner, including any rules or policies on interactions with your organization and reporting or exceptions to the data collection process. When all parties are engaged and informed, a better relationship is built between the parties and the credibility of the organization is increased.
Once the organization has identified the key players and compliance goals and objectives, the right vendors and external resources can be instituted to ensure data on compliant HCP interactions are collected and reported in an accurate and timely manner.
Check back in at AHM Voice to read Part 2 in this series, which will look at the perspective of the third party or vendor to identify challenges and recommend solutions for improving the compliance process.
Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM
Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.